MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM ENURESIS ALARM; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number ULTIMATE

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Choking (2464)

Event Date 07/08/2019

Event Type  Injury  

Event Description

I bought the malem ultimate bedwetting alarm for my (b)(6) daughter and used it last night for the first time.I attached the sensor to her underwear (she wore a pull-up on the outside of her underwear to protect the bed) and the alarm with the cord attached to her shirt.I woke up this morning to find her sound sleep with the cord wrapped around her neck and a wet pullup and underwear.I panicked, first thinking she was asphyxiated given the fact that she basically had strangled herself with the cord by tossing and turning throughout the night, and then when i realized she was sleeping, she turned over and the alarm went off.I am shocked that there is not a warning on this product given the potential strangulation hazard and am just ill thinking about what might have happened if the cord would have tightened around her neck while she was sleeping.Fda safety report id# (b)(4).

• Brand Name: MALEM ENURESIS ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD. ; nottingham ; UK
• MDR Report Key: 8785221
• MDR Text Key: 151006155
• Report Number: MW5088042
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ULTIMATE
• Device Catalogue Number: BLUE COLOR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR